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Thyroid CancerPhase 2Mec-HFS-TCNCT07911891

Oral Mecobalamin for TKI-Associated Hand-Foot Syndrome in Advanced Thyroid Cancer

A Phase 2 study testing Mecobalamin and Urea Ointment in people with Thyroid Cancer and Hand-foot Syndrome, run by Li Zhihui at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates the efficacy and safety of oral mecobalamin for the treatment of tyrosine kinase inhibitor (TKI)-associated hand-foot syndrome (HFS) in patients with advanced thyroid cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Thyroid Cancer, Hand-foot Syndrome
What is being tested?
Mecobalamin and Urea Ointment
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteChina
Study dates
12 Apr 2025to 12 Mar 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically confirmed advanced thyroid cancer (including papillary, follicular, medullary, and other types)
  • Currently receiving TKI therapy (sorafenib, lenvatinib, cabozantinib, etc.)
  • Developed TKI-related hand-foot syndrome, CTCAE v5.0 grade 1-3
  • Age 18-75 years, either gender
  • Estimated survival time ≥3 months
  • Voluntarily signed informed consent form

Who cannot join

  • Pre-existing primary peripheral neuropathy, diabetic foot, severe skin disease, or hand/foot trauma
  • Concomitant vitamin B12 deficiency or requiring long-term vitamin B12 supplementation
  • Allergy to mecobalamin or urea ointment components
  • Pregnant or lactating women
  • Received other drugs for HFS treatment within 4 weeks before enrollment
  • Severe cardiac, hepatic, or renal dysfunction
  • Inability to cooperate with follow-up

Trial locations and contacts

1 site in 1 country.

China1 site

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: Oral Mecobalamin for the Treatment of Tyrosine Kinase Inhibitor-Associated Hand-Foot Syndrome in Patients With Advanced Thyroid Cancer: A Single-Center, Open-Label, Randomized Controlled Trial

This study evaluates the efficacy and safety of oral mecobalamin for the treatment of tyrosine kinase inhibitor (TKI)-associated hand-foot syndrome (HFS) in patients with advanced thyroid cancer. 100 patients will be randomly assigned to receive either routine skin care with topical urea ointment alone (control group) or routine skin care plus oral mecobalamin (0.5 mg three times daily) for 8 weeks. The primary outcome is the proportion of patients with HFS grade improvement at week 8.

Read the detailed description

Background: Hand-foot syndrome is a common skin toxicity associated with TKI therapy in advanced thyroid cancer, which often leads to dose reduction or treatment discontinuation. There is currently no standard effective treatment for TKI-related HFS. Mecobalamin, as an active form of vitamin B12, has been widely used for peripheral neuropathy and may have a therapeutic effect on HFS by improving nerve repair and reducing inflammation.

Methods: This is a single-center, open-label, randomized controlled trial conducted at West China Hospital, Sichuan University. Eligible patients are those with advanced thyroid cancer receiving TKI therapy who develop HFS (Common Terminology Criteria for Adverse Events (CTCAE) grade 1-3). Patients will be randomized 1:1 to either the control group (routine skin care with topical urea ointment 3 times daily) or the mecobalamin group (routine skin care plus oral mecobalamin 0.5 mg 3 times daily) for 8 weeks. The primary endpoint is the proportion of patients with HFS grade improvement ≥1 from baseline to week 8. Secondary endpoints include changes in VAS (visual analog scale) pain score, KPS (Karnofsky Performance Status) performance status, TKI dose adjustment rate, and adverse events.

Being tested
Mecobalamin, Urea Ointment
Keywords
Thyroid neoplasms, Protein kinase inhibitors, ThyrHand-foot syndrome, Mecobalamin, Randomized controlled trial
Medical subject headings
Thyroid Neoplasms, Hand-Foot Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MecobalaminDrug

    Also called Methylcobalamin

    Oral mecobalamin 0.5 mg, 3 times daily, for 8 weeks.

  • Urea OintmentOther

    Topical urea ointment applied to hands and feet 3 times daily, for 8 weeks.

Study groups in NCT07911891
Study groupRoleWhat they receive
Control GroupPlacebo comparatorPatients receive routine skin care with topical urea ointment 3 times daily for 8 weeks.
Receives: Other: Urea Ointment
Mecobalamin GroupExperimentalPatients receive routine skin care plus oral mecobalamin 0.5 mg 3 times daily for 8 weeks.
Receives: Drug: Mecobalamin; Other: Urea Ointment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with HFS grade improvement ≥1 at week 8

    HFS grade is assessed by CTCAE v5.0 criteria. Improvement ≥1 grade means the HFS severity decreases by at least one level from baseline to week 8.

    Measured: Week 8

Secondary outcomes (4)

  1. Change in VAS pain score from baseline to week 8

    VAS pain score ranges from 0 (no pain) to 10 (worst pain). Change score = baseline score - week 8 score.

    Measured: Week 8

  2. Change in KPS performance status from baseline to week 8

    KPS score ranges from 0 (death) to 100 (normal activity). Change score = week 8 score - baseline score.

    Measured: Week 8

  3. Proportion of patients requiring TKI dose adjustment due to HFS

    Patients who require TKI dose reduction, interruption, or discontinuation due to HFS during the 8-week study period.

    Measured: 8 weeks

  4. Incidence of adverse events related to study medication

    All adverse events assessed by CTCAE v5.0 criteria, classified as related or unrelated to study medication.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2026
  2. Study start12 Apr 2025
  3. Primary completion28 Dec 2025
  4. Study completion12 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07911891
Sponsor's protocol ID
WCH-2024-2356
Other IDs
GP202501202410
Acronym
Mec-HFS-TC
Status last verified
Nov 2026
First submitted
25 Oct 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mai W, Wei A, Lin X, Wang F, Ye J, Chen P. Efficacy and safety of traditional Chinese medicine injection with mecobalamin in treating diabetic peripheral neuropathy: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2021 Jan 8;100(1):e23702. doi: 10.1097/MD.0000000000023702.

    PubMed 33429738

  • Fleeman N, Houten R, Bagust A, Richardson M, Beale S, Boland A, Dundar Y, Greenhalgh J, Hounsome J, Duarte R, Shenoy A. Lenvatinib and sorafenib for differentiated thyroid cancer after radioactive iodine: a systematic review and economic evaluation. Health Technol Assess. 2020 Jan;24(2):1-180. doi: 10.3310/hta24020.

    PubMed 31931920

  • Minaldi E, Cappagli V, Lorusso L, Valerio L, Giani C, Viglione M, Agate L, Molinaro E, Matrone A, Elisei R. Hand-foot syndrome in sorafenib and lenvatinib treatment for advanced thyroid cancer. Eur Thyroid J. 2024 Jul 29;13(4):e240009. doi: 10.1530/ETJ-24-0009. Print 2024 Aug 1.

    PubMed 38954633

  • Baskarane H, Sahni S, Nagpal C, Divakar MK, Pathak N, Kumar S, Bakhshi S, Sagiraju HKR, Singh PP, Agarwal R, Hooda V, Vasudeva P, Batra A. Preventing Hand-Foot Syndrome in Patients With Cancer: A Systematic Review and Network Meta-Analysis. JAMA Dermatol. 2026 Apr 1;162(4):386-394. doi: 10.1001/jamadermatol.2026.0042.

    PubMed 41779386

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mecobalamin and Urea Ointment in people with Thyroid Cancer and Hand-foot Syndrome, run by Li Zhihui at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with HFS grade improvement ≥1 at week 8 (time frame: Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07911891, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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